Onsite Senior Validation Engineer - GMP/Pharma Systems

Zachary Piper Solutions; Clayton (NC); On-site; USD 102,000 - 116,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Sick Leave

401K

Job summary

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract position located in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes while supporting large-scale pharmaceutical production projects in a regulated GMP environment.

Responsibilities include developing, executing, and reporting IV, OV, and PV protocols; managing

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field.
• 7+ years of validation experience in regulated manufacturing environments.
• Strong knowledge of GMP, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and CSV principles.
• Experience with automated manufacturing equipment validation, change management, and investigations.
• Proven leadership with multiple projects, timelines, and cross-functional teams.

Responsibilities

• Lead IV/OV/PV protocol development, execution, analysis, and reporting for manufacturing equipment and processes.
• Manage validation-related change controls and ensure regulatory compliance.
• Author and maintain validation plans, quality records, procedures, and specifications.
• Drive investigations for deviations, failures, and nonconformances using root-cause methodologies.
• Support FAT, SAT, commissioning, and startup activities; coordinate schedules and stakeholders.

Skills

GMP

Root cause analysis

Project leadership

Cross-functional collaboration

Education

Bachelor's in Engineering

Job description

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract position located in Clayton, NC. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes while supporting large-scale pharmaceutical production projects in a regulated GMP environment.

Responsibilities include developing, executing, and reporting IV, OV, and PV protocols; managing